Physical Activity and Nutritional Education as School-based Interventions to Control Obesity in Children and Adolescents (PANE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00985972
First received: September 23, 2009
Last updated: November 3, 2010
Last verified: April 2010
  Purpose

The hypothesis of this study focuses on obtaining accurate information on the effectiveness of interventions involving physical activity or nutrition education developed in the school environment. This study is intended to assist in future assembly and development of effective school practices related to preventing and reducing levels of overweight in children and adolescents by means of physical activity and nutrition education.

Updated data from the systematic review:

4677 studies retrieved from 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC, ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services Abstracts, Sociological Abstracts, SPORTDiscus)

1110 were excluded as duplicates by Eppi Reviewer

3567 studies referred for evaluation by title and abstracts

Of these, 187 studies were included by two reviewers (JS and PG) + 17 papers were included by consensus of three reviewers (PG MN, and JS).

Next steps:

  1. Search cross references on systematic reviews / meta-analysis related with purpose to include them;
  2. Select the main"slice" of the "salami publications";
  3. Reaching the final number of papers to make the full text assessment by GRADE and EPHPP assessment tool.

Condition Intervention
Overweight
Obesity
Behavioral: Physical Activity and Nutrition Education

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Physical Activity and Nutritional Education as School-based Interventions to Control Overweight in Children and Adolescents: a Systematic Review

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Evaluate the effectiveness of interventions that use physical activity and nutrition education in the school environment to control of body weight through anthropometric indicators, such as body weight, body mass index, skinfolds, circumferences data. [ Time Frame: Assessments results should at least monitor the execution time of the intervention studies, with a minimum of two assessments: pre-and post-intervention. This requirement depends directly on the studies to be extracted in the systematic search. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate these interventions in the perspective of social equity, as the differences between public and private schools, rural and urban, developed and developing countries. [ Time Frame: requirement for pre and post-intervention assessments ] [ Designated as safety issue: Yes ]
  • Check the influence of interventions that use physical activity and nutrition education programs for health promotion focused in lifestyle. [ Time Frame: requirement for pre and post-intervention assessments ] [ Designated as safety issue: Yes ]
    Assess the impact of school interventions in relation to the acquisition of healthy habits such as physical activity and increased consumption of healthy foods

  • Analyze the impact of interventions that uses physical activity and nutrition education in schools such as curriculum or program included in the planning education. [ Time Frame: requirement for pre and post-intervention assessments ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: June 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
Groups of school intervention that involves a combination of the physical activity and nutrition education in subjects 6 to 15 years of age
Behavioral: Physical Activity and Nutrition Education
School-based interventions involving Physical Activity or/and Nutrition Education.
Control
Groups included in the same school communities that serve as reference for individuals involved in intervention.
Behavioral: Physical Activity and Nutrition Education
School-based interventions involving Physical Activity or/and Nutrition Education.

Detailed Description:

The inordinate increase in the prevalence of overweight and obesity at the international level today is one of the targets of concern the department of public health, and gradually has been the focus of many studies and interventions which emphasize the need for more evidence to clear and effective its prevention and reduction. Obesity can affect the short or long term health of individuals, through problems such as left ventricular hypertrophy in young-adult and atherosclerosis, which is due to the formation of plaques of fat in the arterial wall and may lead to coronary artery disease , cerebrovascular disease and peripheral vascular disease.

The promotion of regular practice of physical activity through physical education school can be an effective way to prevent obesity among children, especially girls. There is an inverse relationship between physical activity and incidence of hypertension. The earlier the entrance to the practice of physical activities, there will be more effective in combating the increase in body mass index (BMI).

Nutrition Education is to extend the knowledge on nutrition and the ability to understand the practices and eating behavior, improving the relationship of the individual in the environment which is introduced, allowing the taking of decisions under the situation presented.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children and adolescents aged 6 to 15 years of age included in the school environment, regardless of their ethnicity, social condition and weight range.

Criteria

Inclusion Criteria:

  • Randomized clinical / community trials whose main objective is the focus on control and / or reduction of body weight of the participants, conducted by a program developed in the scholar environment that promotes the practice of physical activity and healthy eating through nutrition education.
  • Studies that include participants aged 06 to 15 years of age, regardless of the range of weight.
  • There is no restriction ethnic, social, gender, nutritional status and physical fitness.
  • There is no limitation of language for critical evaluation of studies.

Exclusion Criteria:

  • Studies making use of pharmacological agents
  • Studies with participants who suffer from diseases except obesity
  • Studies not conducted in the school environment
  • Interventions lasting less than 12 weeks.
  • The duplicated data will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985972

Contacts
Contact: Paulo HA Guerra (11) 30695941 paulohguerra@usp.br

Locations
Brazil
Heart Institute, General Hospital of Faculty of Medicine of University of Sao Paulo (InCor HCFMUSP) Recruiting
Sao Paulo, Brazil
Contact: Moacyr RC Nobre, PhD     30695941     mrcnobre@usp.br    
Contact: Paulo HA Guerra     30695417     paulohguerra@usp.br    
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Moacyr MR Nobre, PhD University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit
Principal Investigator: Paulo Henrique A Guerra, Bachelor University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit
Principal Investigator: Jonas A Silveira, Specialist Federal University of São Paulo, Department of Pediatrics
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Moacyr Roberto C. Nobre, PhD., University of São Paulo, Faculty of Medicine, Heart Institute (InCor FMUSP), Clinical Epidemiology Unit
ClinicalTrials.gov Identifier: NCT00985972     History of Changes
Other Study ID Numbers: PANE0575-08
Study First Received: September 23, 2009
Last Updated: November 3, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
PHYSICAL ACTIVITY
SCHOOL
NUTRITION
EDUCATION
OVERWEIGHT

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013